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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00362830 |
The purpose of the study is to test how vinflunine interacts with ixabepilone in the human body.
Condition | Intervention | Phase |
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Cancer |
Drug: vinflunine + ixabepilone |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Study of the Alternating Administration of Ixabepilone and Vinflunine Every Three Weeks in Patients With Advanced Cancer |
Estimated Enrollment: | 60 |
Study Start Date: | August 2006 |
Study Completion Date: | September 2007 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: vinflunine + ixabepilone
solution for injection, IV, vinflunine: 250 to 320 mg/m2 + ixabepilone: 30 to 40 mg/m2, every 3 wks, variable duration
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
University Of Miami Miller School Of Medicine | |
Miami, Florida, United States, 33136 | |
United States, Ohio | |
The Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44195 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | CA183-008 |
Study First Received: | August 7, 2006 |
Last Updated: | July 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00362830 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Epothilones Tubulin Modulators Antimitotic Agents |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Epothilones |
Mitosis Modulators Tubulin Modulators Antimitotic Agents Pharmacologic Actions |